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The proposed study will evaluate the performance of fluoride delivered from a new dentifrice formulation without potassium nitrate. It will also evaluate the dose-response to fluoride by testing four dentifrices covering a range of sodium fluoride concentration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low ppm fluoride dentifrice | Experimental | Low ppm fluoride as sodium fluoride in a silica base dentifrice |
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| Medium ppm fluoride dentifrice | Experimental | Medium ppm fluoride as sodium fluoride in a silica base dentifrice |
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| High ppm fluoride dentifrice | Experimental | High ppm fluoride as sodium fluoride in a silica base dentifrice |
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| No fluoride dentifrice | Placebo Comparator | no added fluoride in a silica base dentifrice |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sodium fluoride | Drug | fluoride as sodium fluoride |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship | SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100. | Baseline to 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| %SMHR | SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Dentistry | Indianapolis | Indiana | 46202 | United States |
A total of 72 participants were screened, and 62 were randomized into the study. 9 participants did not meet the study criteria and 1 withdrew consent. A washout non-fluoridated toothpaste was used for 2 days prior treatment. In-situ appliances were prepared for participants to fit enamel specimens.
Participants were recruited at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sodium Fluoride (NaF) Dentifrice,1426 Parts Per Million(Ppm)F | Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 grams (g) ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided. |
| FG001 | NaF Dentifrice (1150ppmF) | Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided. |
| FG002 | NaF Dentifrice (250ppmF) | Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided. |
| FG003 | Placebo Dentifrice (0ppmF) | Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period I |
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| Period II |
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| Period III |
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| Period IV |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Randomized Participants | All randomized participants who received at least one dose of the study treatments. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship | SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100. | Per protocol population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing values were not imputed. | Posted | Mean | Standard Error | %SMHR | Baseline to 4 hours |
|
All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NaF Dentifrice (1426 ppmF) | Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mouth Ulceration | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D012969 | Sodium Fluoride |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
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| no added fluoride in a silica base | Drug | no added fluoride |
|
| Baseline to 4 hours |
| Percentage Relative Erosion Resistance | Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine relative erosion resistance which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent relative erosion resistance was calculated by formula: [(E1-E2)/ (E1-B)]*100. | Baseline to 4 hours |
| Enamel Fluoride Uptake (Corrected Data) | Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of fluoride divided by area of the enamel cores. Data analysis was based on corrected data. | Baseline to 4 hours |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided. |
| OG001 | NaF Dentifrice (1150 ppmF) | Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided. |
| OG002 | NaF Dentifrice (250 ppmF) | Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided. |
| OG003 | Placebo Dentifrice (0 ppmF) | Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided. |
|
|
|
| Secondary | %SMHR | SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100. | PP population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing values were not imputed. | Posted | Mean | Standard Error | %SMHR | Baseline to 4 hours |
|
|
|
|
| Secondary | Percentage Relative Erosion Resistance | Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine relative erosion resistance which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent relative erosion resistance was calculated by formula: [(E1-E2)/ (E1-B)]*100. | PP population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing values were not imputed. | Posted | Mean | Standard Error | % Relative Erosion Resistance | Baseline to 4 hours |
|
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|
|
| Secondary | Enamel Fluoride Uptake (Corrected Data) | Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of fluoride divided by area of the enamel cores. Data analysis was based on corrected data. | PP population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing values were not imputed. Data analysis for this outcome measure was performed based on a correction factor. | Posted | Mean | Standard Error | micrograms*F/centimeters^2 | Baseline to 4 hours |
|
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| 0 |
| 62 |
| 3 |
| 62 |
| EG001 | NaF Dentifrice (1150 ppmF) | Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. | 0 | 61 | 6 | 61 |
| EG002 | NaF Dentifrice (250 ppmF) | Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. | 0 | 62 | 1 | 62 |
| EG003 | Placebo Dentifrice (0 ppmF) | Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. | 0 | 60 | 4 | 60 |
| Nasopharyngitis | Infections and infestations |
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| Tooth Abscess | Infections and infestations |
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| Cough | Respiratory, thoracic and mediastinal disorders |
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| Sinus Headache | Nervous system disorders |
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| Cheilitis | Gastrointestinal disorders |
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| Mouth Injury | Injury, poisoning and procedural complications |
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| Tongue Hematoma | Gastrointestinal disorders |
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| Myalgia | Musculoskeletal and connective tissue disorders |
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| Abdominal Pain, Upper | Gastrointestinal disorders |
|
| Sensitivity of teeth | Gastrointestinal disorders |
|
| Headache | Nervous system disorders |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D017670 |
| Sodium Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| Null hypothesis considered no dose-response relationship between %SMHR and fluoride concentration in the dentifrice. | ANOVA | ANOVA with fixed factors for study period and treatment and the subject as random effect. | 0.0009 | No adjustment was required for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 5.60 | 2-Sided | 95 | 2.35 | 8.86 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis considered treatments in comparison to be equal. | ANOVA | ANOVA with fixed factors for study period and treatment and the subject as random effect. | 0.0389 | No adjustment was required for multiple comparisons as the primary comparison was pre-specified. | Adjusted Mean Difference | 3.43 | 2-Sided | 95 | 0.18 | 6.68 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis considered treatments in comparison to be equal. | ANOVA | ANOVA with fixed factors for study period and treatment, and subject as random effect. | <0.0001 | No adjustment was required for multiple comparisons as primary comparison was pre-specified. | Adjusted Mean Difference | 9.86 | 2-Sided | 95 | 6.58 | 13.13 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis considered treatments in comparison to be equal. | ANOVA | ANOVA with fixed factors for study period and treatment, and subject as random effect. | <0.0001 | No adjustment was required for multiple comparisons as primary comparison was pre-specified. | Adjusted Mean Difference | 7.68 | 2-Sided | 95 | 4.41 | 10.96 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis considered treatments in comparison to be equal. | ANOVA | ANOVA with fixed factors for study period and treatment, and subject as random effect. | 0.0112 | No adjustment was required for multiple comparisons as primary comparison was pre-specified. | Adjusted Mean Difference | 4.25 | 2-Sided | 95 | 0.98 | 7.53 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
Test for quadratic dose-response relationship was performed for %RER as a function of fluoride concentration. |
| ANOVA |
| 0.0002 |
| 95 |
| No |
| Superiority or Other |
| Null hypothesis considered no difference between treatments, being compared. | ANOVA | ANOVA with fixed factors for study period and treatment, while subject was random effect. | <0.0001 | No adjustment was required for multiple comparisons as primary comparison was pre-specified. | Adjusted Mean Difference | 32.38 | 2-Sided | 95 | 25.18 | 39.59 | Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis considered no difference between treatments, being compared. | ANOVA | ANOVA with fixed factors for study period and treatment, while subject was random effect. | <0.0001 | No adjustment was required for multiple comparisons as primary comparison was pre-specified. | Adjusted Mean Difference | 31.46 | 2-Sided | 95 | 24.25 | 38.67 | Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis considered no difference between treatments, being compared. | ANOVA | ANOVA with fixed factors for study period and treatment, while subject was random effect. | <0.0001 | No adjustment was required for multiple comparisons as primary comparison was pre-specified. | Adjusted Mean Difference | 20.81 | 2-Sided | 95 | 13.60 | 28.02 | Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis considered no difference between treatments, being compared. | ANOVA | ANOVA with fixed factors for study period and treatment, while subject was random effect. | 0.8000 | No adjustment was required for multiple comparisons as primary comparison was pre-specified. | Adjusted Mean Difference | 0.92 | 2-Sided | 95 | -6.25 | 8.10 | Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis considered no difference between treatments, being compared. | ANOVA | ANOVA with fixed factors for study period and treatment, while subject was random effect. | 0.0017 | No adjustment was required for multiple comparisons as primary comparison was pre-specified. | Adjusted Mean Difference | 11.57 | 2-Sided | 95 | 4.40 | 18.74 | Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis considered no difference between treatments, being compared. | ANOVA | ANOVA with fixed factors for study period and treatment, while subject was random effect. | 0.0038 | No adjustment was required for multiple comparisons as primary comparison was pre-specified. | Adjusted Mean Difference | 10.65 | 2-Sided | 95 | 3.48 | 17.81 | Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
Test for quadratic dose-response relationship was performed for EFU as a function of fluoride concentration. |
| ANOVA |
Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor. |
| 0.0008 |
| 95 |
| No |
| Superiority or Other |
| Null hypothesis considered no difference between treatments, being compared. | ANOVA | ANOVA with fixed factors for study period and treatment, while subject was random effect. | <0.0001 | No adjustment was required for multiple comparisons as primary comparison was pre-specified. | Adjusted Mean Difference | 1.66 | 2-Sided | 95 | 1.42 | 1.90 | Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis considered no difference between treatments, being compared. | ANOVA | ANOVA with fixed factors for study period and treatment, while subject was random effect. | <0.0001 | No adjustment was required for multiple comparisons as primary comparison was pre-specified. | Adjusted Mean Difference | 1.60 | 2-Sided | 95 | 1.36 | 1.85 | Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis considered no difference between treatments, being compared. | ANOVA | ANOVA with fixed factors for study period and treatment, while subject was random effect. | <0.0001 | No adjustment was required for multiple comparisons as primary comparison was pre-specified. | Adjusted Mean Difference | 0.62 | 2-Sided | 95 | 0.38 | 0.86 | Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis considered no difference between treatments, being compared. | ANOVA | ANOVA with fixed factors for study period and treatment, while subject was random effect. | 0.6680 | No adjustment was required for multiple comparisons as primary comparison was pre-specified. | Adjusted Mean Difference | 0.05 | 2-Sided | 95 | -0.19 | 0.29 | Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis considered no difference between treatments, being compared. | ANOVA | ANOVA with fixed factors for study period and treatment, while subject was random effect. | <0.0001 | No adjustment was required for multiple comparisons as primary comparison was pre-specified. | Adjusted Mean Difference | 1.04 | 2-Sided | 95 | 0.80 | 1.28 | Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis considered no difference between treatments, being compared. | ANOVA | ANOVA with fixed factors for study period and treatment, while subject was random effect. | <0.0001 | No adjustment was required for multiple comparisons as primary comparison was pre-specified. | Adjusted Mean Difference | 0.99 | 2-Sided | 95 | 0.75 | 1.23 | Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |